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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow International 4FR Single Lumen Pressure Injectable PICC.

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  Class 2 Device Recall Arrow International 4FR Single Lumen Pressure Injectable PICC. see related information
Date Initiated by Firm September 18, 2015
Date Posted October 15, 2015
Recall Status1 Terminated 3 on June 25, 2020
Recall Number Z-0127-2016
Recall Event ID 72244
510(K)Number K061289  K073451  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Code Information Material Numbers: ASK-05041-CHC2 ASK-05041-LM4 ASK-05041-QV ASK-05541-MS3 CA-05041-HP CA-05041-HPX CDC-04041-HPK1A CH-04041-HMA EU-04041-HP EU-05041-HPMSB EU-05541-HP EU-05541-HPMSB EU-24041-HP EU-24041-HPMSB EU-24041-IR EU-25041-HP EU-25041-HPMSB EU-25041-IR EU-25541-HP EU-25541-HPMSB EU-25541-IR FR-04041 FR-04041-CF FR-05041 FR-05041-CF PR-04041-HPX PR-05041-HP PR-05541-HPX UK-04041-RDE1 UK-04041-THT UK-05041-HPMIN UK-05041-MSB UK-05041-RDE1 UK-05041-THT with Batch Nos. 23F15E0620 23F15A0584 23F14H0964 23F14F1422 23F13J0289 23F13H0832 23F15C2435 23F14L0090 23F14H0848 23F14F0370 23F14A1352 23F13K0761 23F14H0193 23F15C1236 23F14M0484 23F14L0810 23F14K1361 23F14J0415 23F14E1093 23F14B0844 23F15D0881 23F14L0187 23F15F0752 23F15A1857 23F15D0830 23F14H1112 23F14F1497 23F14C1096 23F14C0640 23F14A1238 23F14A1419 23F14L1144 23F14J1513 23F15D0832 23F15F0147 23F15C0303 23F14J0221 23F14F1504 23F14C0643 23F13K0097 23F13H0994 23F13H0013 23F15F0151 23F15C1553 23F15B0400 23F14K1025 23F14H0328 23F14F1505 23F14C0598 23F13K0003 71F14L0736 71F14K1846 71F15B1940 71F13M1092 71F13L0510 71F14A1536 71F14C0247 71F14B1735 71F14F1289 71F14E2029 71F14J1087 71F14K0628 71F14K0081 71F14L0762 71F14L0323 71F14M0678 71F15A0395 71F15B0648 71F15C0214 71F15D0234 71F15D0053 71F15D1075 23F14G1130 23F14F0115 23F14C0576 23F14A1241 23F13K1064 23F13H0034 23F15D1021 23F14D0713 23F14C0575 23F14A1240 23F13K1065 23F13J1118 23F13H0692 71F13G0655 71F13H1053 71F13H0599 71F13H0225 71F13J0124 71F13J1293 71F13K1289 71F13M0785 71F14A1326 71F14B0312 71F14B0879 71F14E1533 71F14E1967 71F14F1290 71F14G0365 71F14F1358 71F14H0351 71F14H0947 71F14J0869 71F14H1396 71F14K0622 71F14K0082 71F14K1332 71F14M0141 71F15A0152 71F15A1289 71F15A1984 71F15B0638 71F15C1137 71F15D0272 71F15D1059 23F14D1125 23F14D0217 23F14B1013 71F15D1630 71F15F1435 71F14J1734 71F14H1167 71F14M0143 71F15B0996 71F15B0224 71F15C0128 71F15D0578 71F15C1592 71F15D1983 71F15E1582 71F15F1737 71F15E1216 71F15D1909 71F14J1735 71F14H1165 71F15A0163 71F15B0228 71F15C0812 71F15C0215 71F15D0682 71F15D0222 71F15D1717 71F15F1736 71F15E1217 71F15F1863 71F15E1185 71F15F1436 71F15F1310 71F15F2106 71F14H0441 71F14L0582 71F14M0144 71F14M0820 71F15A0123 71F15B1011 71F15A1661 71F15C1593 71F15E0165 71F15F1731 71F15E1220 71F14K1569 71F15D0052 71F13L0991 71F13M1110 71F13M0627 71F14A0698 71F14C0579 71F14D0710 71F14F1217 71F14H0374 71F14J1086 71F14K1198 71F14L1345 71F15A1660 71F15B1938 71F15D1077 71F15D0235 71R15E0455 71F15F1185 71F14K1571 71F13G0162 71F13K1107 71F14A1940 71F14A0150 71F14E2043 71F14F1786 71F14F1844 71F14G1690 71F14K0639 71F14L0577 71F14L1347 71F15A1302 71F15B0662 71F15B1937 71F15D0681 71F15E1403 71F14B1741 71F14E0087 71F14E2044 71F14F1785 71F14J1860 71F15A0300 71F15C2011 71F15E1405 23F14E0187 23F15F0261 23F15E1682 23F15D1561 23F15C1091 23F15D0167 23F15B1878 23F15B0293 23F15A1295 23F15A0633 23F14M0574 23F14K1394 23F14K0462 23F14H1536 23F14G1210 23F14E0751 23F14B0822 23F13J1010 23F13J0221 23F13H0876 RF3065299 23F15F1564 23F15B2204 23F14H1433 23F14E0655 23F14E0173 23F14B1161 23F13K0564 23F14B0718 71F15D0580 71F15D1773 71F13J1276 71F13L0902 71F14C1183 71F14E1122 71F14K1663 71F14L0428 71F15A0864 71F15D1722 71F13L1104 71F13L0390 71F14A1957 71F14A0047 71F14C0588 71F14C1362 71F14G0670 71F14K1035 71F14K0409 71F14L1351 71F14L1201 71F14M0821 71F15B0782 71F15F1735 71F15C0829 71F15D0583 71F13J1277 71F14B0311 71F14D1628 71F14E1530 71F14H0659 71F14J1738 71F14L0743 71F14M0328 71F15A0161 
Recalling Firm/
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Customer Support
Manufacturer Reason
for Recall
Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
FDA Determined
Cause 2
Under Investigation by firm
Action An urgent medical device notification, dated September 22, 2015, was sent to direct accounts to alert them about the issue, the potential risks, and provide instructions for returning the completed response form and affected devices.
Quantity in Commerce 31590
Distribution Worldwide distribution. US Nationwide, Australia, Canada, and New Zealand.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LJS and Original Applicant = ARROW INTERNATIONAL, INC.